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March 2015

The General Court of the CJEU has ruled in Teva v the European Medicines Agency (Case T-140/12) that a second, similar, orphan medicinal product that has been granted orphan designation for the same indication as the first is entitled to an independent 10-year period of orphan market exclusivity when it has been approved independently from the first authorised orphan medicinal product.

In this case, imatinib (Glivec) was granted orphan status and received a marketing authorisation in 2001.  It therefore benefited from market exclusivity until 2011 for similar products for the same indication.  Subsequently, Novartis developed another  similar product, nilotinib (Tasigna), which also obtained an orphan designation on the basis that it could provide significant benefit for the treatment of chronic myeloid leukaemia ("CML") because it might improve the long-term outcome of the patients in comparison to the existing products which included imatinib.  A marketing authorisation for Tasigna was granted in 2007, during the marketing exclusivity of Glivec.  Because imatinib and nilotinib were similar medicinal products and were both indicated for CML, it was necessary for consent to be given for the authorisation of Tasigna by the holder of the authorisation for Glivec (the same company, Novartis), as required by Regulation No 141 / 2000 governing orphan medicinal products.

The data exclusivity period of Tasigna for CML does not expire until 2017 and so was still in place at the time that Teva made a marketing authorisation application for generic imatinib.  This application was therefore rejected by the EMA on this basis that imatinib was a similar product indicated for the same indication (CML). In dispute of this, Teva argued before the General Court that the second authorisation, for nilotinib, as a similar second generation product for the same indication was not entitled to a new period of data exclusivity.  If this was not the case, imatinib would effectively be getting an additional period of marketing exclusivity amounting to six years.

Dismissing the action against the EMA's decision, the General Court has confirmed that the 10-year market exclusivity for orphan medicinal products is different to the 8+2 year regime of regulatory data exclusivity. The regulator must not grant a marketing authorisation for a similar product for the same indication as an orphan medicinal product which has been given marketing authorisation for 10 years from the grant of that marketing authorisation.  This applies regardless of the effect on an earlier product for which market exclusivity may have expired.  This is justified, in the Court's judgment, by the purpose of the Regulation as an encouragement to investment in research and development of orphan medicinal products.

General Court ruling

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